Adults 40 to 85, any sex, with Parkinson Disease or Healthy Participants. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Main Cohort: Change From Baseline in Stride Time (Gait) Variability During a 2-minute Dual-Task Walking Test After 6-week Treatment With TAK-071 Compared With PlaceboPrimary· Baseline and Week 6 (for each study period)
Stride time (or gait) is defined as the time elapsed between the first contact of two consecutive footsteps of the same foot and is expressed in seconds. The standard deviation (SD) of the stride time, recorded for each foot during the 2-minutes, is averaged to obtain stride time (gait) variability. The 2-minute walk was performed with and without simultaneous performance of serial 3 subtraction, which adds a cognitive load to the task. Data are reported with and without cognitive load.
Baseline
Group
Value
95% CI
Without Cognitive Load: Placebo
0.0546
± 0.03919
Without Cognitive Load: TAK-071
0.0625
± 0.05601
With Cognitive Load: Placebo
0.0930
± 0.07743
With Cognitive Load: TAK-071
0.0861
± 0.06047
Week 6
Group
Value
95% CI
Without Cognitive Load: Placebo
0.0534
± 0.03638
Without Cognitive Load: TAK-071
0.0607
± 0.05666
With Cognitive Load: Placebo
0.0848
± 0.07894
With Cognitive Load: TAK-071
0.0925
± 0.08156
Sentinel Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in Healthy ParticipantsPrimary· Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-071 in Healthy ParticipantsPrimary· Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in Healthy ParticipantsPrimary· Day 1: Predose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours post dose
Sentinel Cohort, AUClast: Area Under The Concentration-Time Curve From Time 0 To The Last Quantifiable Concentration in Healthy ParticipantsPrimary· Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Sentinel Cohort, AUCinf: Area Under The Concentration-Time Curve From Time 0 To Infinity in Healthy ParticipantsPrimary· Day 1: pre-dose and Day 2 to 8: post-dose and at multiple time-points (up to approximately 168 hours)
Main Cohort: Change From Baseline in Global Cognition Z-scoreSecondary· Baseline and Week 6 (for each study period)
The global cognition score was calculated as the average of the available z-scores derived from the following individual cognitive tests administered in the cognitive test battery: 'Executive Function' assessed by One Back Test, Modified Groton Maze Learning Test, 'Memory' assessed by One Card Learning Test, International Shopping List Test - Immediate and Delayed Recall Tests, and 'Attention' assessed by Sustained Attention Test and Symbol Digit Modalities Test. Each raw score on the individual tests was converted to a z-score. A global z-score was calculated as an average of the individual z
Group
Value
95% CI
Placebo
-0.059
± 0.3671
TAK-071
0.208
± 0.3940
Main Cohort: Ctrough: Observed Concentration at the End of a Dosing Interval for TAK-071 in Parkinson Disease (PD) ParticipantsSecondary· Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Group
Value
95% CI
TAK-071
339
± 43.7
Main Cohort, Cmax: Maximum Observed Plasma Concentration for TAK-071 in PD ParticipantsSecondary· Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Group
Value
95% CI
TAK-071
125
± 33.4
Main Cohort: Cmax,ss: Maximum Observed Plasma Concentration at Steady State for TAK-071 in PD ParticipantsSecondary· Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Group
Value
95% CI
TAK-071
480
± 34.4
Main Cohort: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-071 in PD ParticipantsSecondary· Day 1 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Group
Value
95% CI
TAK-071
2360
± 32.6
Main Cohort, AUCtau: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-071 in PD ParticipantsSecondary· Day 42 of Period 1 and Period 2: pre-dose and at multiple time-points post-dose
Group
Value
95% CI
TAK-071
9360
± 38.3
Adverse events — posted to ClinicalTrials.gov
Time frame: From signing of the informed consent form up to 22 days after the last dose of study treatment (up to approximately 148 days).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
It is hoped that TAK-071 will help people with Parkinson's disease to walk with better balance. The main aim of the study is to check if there is a difference in how participants walk after treatment with TAK-071. Another aim is to see if it improves how participants think and remember.
At the first visit, the study doctor will check who can take part. Participants who can take part will be picked for 1 of 2 groups by chance.
Both groups will have 2 treatments but in a different order. The treatments are TAK-071 tablets or placebo. In this study, a placebo will look like the TAK-071 but will not have any medicine in it.
One group will take TAK-071 for 6 weeks, have at least a 3-week break, then take a placebo for 6 weeks. The other group will take a placebo for 6 weeks, have at least a 3-week break, then take TAK-071 for 6 weeks. The participants will not know the order of their 2 treatments, nor will their study doctors. This is to help make sure the results are more reliable.
The participants will visit the clinic at the beginning and end of each treatment for a check-up. 14 days after the 2nd treatment, clinic staff will telephone the participants for a final check-up.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 14 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04334317.